This invention relates to an improved transfer set for transferring fluid from a first container, such as a conventional vial having a pierceable closure or stopper, and a second container, such as a syringe.
It is conventional to store drugs, vaccines, medicaments and solutions in a sealed vial or other container for later use. Drugs, vaccines, medicaments and solutions may be stored in a dry or powdered form to increase the shelf life and reduce inventory space. Such dry or powdered materials may be stored in a conventional sealed vial having a pierceable closure, such as an elastomeric stopper, and reconstituted in liquid form for later use, such as administration to a patient, by adding a diluent or solvent. Alternatively, such drugs, vaccines, medicaments and solutions may be stored in a liquid or even a gaseous form. A conventional vial for storing such materials in liquid, dry or gaseous form includes an open end, a radial rim portion surrounding the open end and a reduced diameter neck portion adjacent the rim portion. The vial is conventionally sealed with an elastomeric stopper or other pierceable closure which generally includes a tubular portion inserted in the open end in the neck of the vial and a planar rim portion which overlies the vial rim. The stopper is conventionally secured to the vial with a thin malleable metal cap, such as aluminum. Because aluminum is malleable, the collar accommodates the buildup of tolerances of the dimensions on the stopper and vial rim.
Recently, various vial transfer sets have been proposed for transferring fluid between a vial and a conventional syringe, wherein the transfer set is mounted on the vial for later use. The transfer set may include a piercing member, such as a needle canula generally telescopically mounted in a tubular fluid transfer member mounted on the open end of the vial. The transfer set may be enclosed by a cup-shaped closure or housing having a radial flange secured to the vial by a malleable metal or plastic collar.
Transfer sets have been utilized, for example, to transfer fluid from a vial to a syringe, such as a reconstituted dry or powdered drug, vaccine or medicament by adding a diluent or solvent in the syringe. The reconstituted drug may then be withdrawn from the vial by the syringe. The inner surface of the transfer set may be part of the fluid path and the aluminum collar or ring may bring aluminum particles into the sterile room where the drug, vaccine or medicament is added to the vial or into the drug path contaminating the drug, vaccine or medicament. There have been attempts to reduce this problem by applying a protective coating to the aluminum cap or collar. Finally, the prior art also includes snap-on cup-shaped plastic caps or collars having radially inwardly projecting end portion which is snapped over the rim of the vial. Snap-on collars, however, do not assure adequate sealing of the vial or fully accommodate the tolerances of standard vials and stoppers, as required.
The prior art also discloses plastic transfer sets for vials. However, such plastic transfer sets are relatively expensive having several interfitting parts and are difficult to use. The need therefore remains for a transfer set for vials or other containers which may be utilized with conventional vials, such as vials or cartridges used by the medical industry, which assures sealing of the container and which achieves a good level of cleanliness, without particles or dust which may contaminate the drugs, vaccines or medicaments, the transfer set or the clean room, and which does not expose the health care worker to sharp, metal edges. The need also remains for a transfer set which may be easily secured to a vial or other container and which is relatively simple in construction and easy to use.
The improved transfer set of this invention may be utilized, for example, to transfer fluid between a conventional vial having a pierceable closure or stopper and a conventional syringe having a luer threaded connector without a needle canula. However, the transfer set of this invention is universal in that it can be utilized to transfer fluid from any container having a pierceable closure and a second container. The components of the transfer set may be formed of polymers, preferably a polymer which may be sterilized for medical applications. In the most preferred embodiments of the transfer set of this invention, where the collar portion of the tubular housing member is radially deformed or crimped into the reduced diameter neck portion of the vial as described herein, the tubular housing member is preferably formed of a polymer which may be permanently deformed radially to secure the transfer set to the vial or container, yet sufficiently rigid to retain its shape following deformation and resistant to creep to maintain a good seal between the container and the transfer set, thereby avoiding contamination.
The improved transfer set of this invention includes a tubular housing member having a proximate end adapted to be attached to the first container open end and an open distal end. For ease of description only, the term xe2x80x9cproximatexe2x80x9d is used herein to designate the portions of the transfer set closest to the first container or vial to which the transfer set may be attached and the term xe2x80x9cdistalxe2x80x9d is used herein to refer to the portions of the components furthest from the first container. A cap is releasably attached over the open distal end of the tubular housing member, sealing the open distal end. The transfer set further includes a piercing member which is telescopically supported in the tubular housing member having a proximate piercing end adapted to pierce the closure in the open end of the container and a distal end. In the most preferred embodiments of the improved transfer set disclosed herein, the transfer set further includes a tubular transfer member located within the tubular housing member having a proximate end adapted to sealingly engage the pierceable closure in the open end of the first container and an open distal end. In the preferred embodiments disclosed in the above-referenced parent applications, the piercing member is releasably secured by interfering surfaces of the tubular transfer member and the piercing member. Further, the tubular transfer member is integral with the tubular housing member, wherein the tubular transfer member is connected to the tubular housing member by an integral radial web.
In the most preferred embodiment of the transfer set first disclosed in this application, the distal end of the piercing member is releasably attached to the cap simplifying the assembly of the transfer set and assuring release of the piercing member following removal of the cap. The preferred embodiment of the cap includes a central portion overlying the distal open end of the tubular housing member having a central connector portion which receives and releasably retains the distal end of the piercing member. In the most preferred embodiment, the connector portion and the distal end of the piercing member includes a camming surface having a major diameter greater than the internal diameter of the tubular connector portion of the cap, providing an interference fit. In the disclosed embodiment, the camming surface on the free distal end of the piercing member is generally spherical or semi-spherical terminating in a relatively sharp edge which bites into the internal surface of the central tubular portion of the cap, thereby releasably retaining the piercing member to the cap. The preferred embodiment of the cap further includes an outer tubular portion which is received around the distal open end of the tubular housing member having a frangible connector portion adjacent the central portion, such as an annular groove. Thus, the central portion of the cap may be removed and the piercing member is retained by the cap until the central portion is removed. The disclosed embodiment of the cap further includes an inner tubular portion concentric with the outer tubular portion adjacent to but spaced from the outer tubular portion which is received within the open distal end of the tubular housing member assuring a good seal of the open distal end of the tubular housing member. Further, in the disclosed embodiment, the outer surface of the tubular housing member adjacent the open distal end includes an annular radial rib which is received in an annular groove in the interior surface of the outer tubular portion of the cap preferably located adjacent to the frangible connector portion assuring retention of the cap on the tubular housing member prior to removal of the central portion.
The most preferred embodiment of the generally tubular transfer member is retained to the tubular housing member by an integral radially inwardly projecting rib extending from the internal surface of the tubular transfer member. The tubular transfer member preferably includes a camming surface, which in the disclosed embodiment is frusto-conical, having an annular end surface received on the radially inwardly projecting rib of the tubular housing member. The frusto-conical surface has a major diameter which is greater than the internal diameter of the radially inwardly projecting rib, such that the tubular transfer member may be inserted into the housing member from the proximate open end, wherein the camming surface resiliently biases the radially inwardly projecting rib of the tubular housing member out of the way for receipt of the annular end surface of the camming surface on the radially inwardly projecting rib of the tubular housing member. In the most preferred embodiment of the tubular transfer member, the external surface adjacent the open distal end includes a luer thread for receipt of a conventional female luer thread of a syringe or other container, providing fluid communication between the first container and the second container through the tubular transfer member. The piercing member in the disclosed embodiment includes a V-shaped external channel which provides fluid communication between the first container following piercing of the closure by the piercing member and the second container. It will be understood, however, that the piercing member may include a longitudinal passage or an interrupted external passage of any shape depending upon the application.
In one preferred embodiment of the improved transfer set of this invention, rotation of the tubular transfer member is prevented during threaded attachment of a syringe or other container by interlocking longitudinally extending ribs on the external surface of the tubular transfer member and the internal surface of the tubular housing member. Although only one rib is required on each of the tubular transfer member and the tubular housing member, the disclosed embodiment includes three ribs. In the alternative embodiment, the proximate end of the tubular transfer member includes a radial portion which is compressed against the resilient stopper during assembly, preventing rotation of the tubular transfer member relative to the tubular housing member. As will be understood, however, other means may be utilized to prevent rotation of the tubular transfer member during threaded attachment to the second container or the anti-rotation means may be eliminated where the second container is not threaded to the tubular transfer member.
Where the improved transfer set of this invention is to be sealingly attached to a vial or other container having a rim portion surrounding the open end and a reduced diameter neck portion, the proximate end of the tubular housing member preferably includes an integral radial portion adapted to overlie the rim portion of the closure or stopper and a tubular collar portion integral with the radial portion. In the most preferred embodiment, where the tubular housing member is formed of a polymer as described above, the free end of the tubular collar portion is deformed radially inwardly or crimped into the neck portion of the vial or other container permanently attaching the tubular transfer member to the first container. Having described the components of the preferred embodiments of the tubular transfer member of this invention, the assembly may now be described.
In the embodiments of the tubular transfer member first described in the above-referenced parent applications, the piercing member is inserted into the tubular transfer member and is retained therein by interlocking ribs and grooves on the piercing member and the tubular transfer member. The cover or cap is attached to the open distal end of the tubular housing member either by adhesive bonding in one embodiment or by inserting the inner tubular portion of the cap into the open distal end of the tubular housing member which receives the outer tubular portion around the open distal end. In the preferred embodiment first disclosed in this application, the tubular transfer member is separate from the tubular housing member as described. The tubular transfer member is then inserted into the open proximate end of the tubular housing member and then driving the frusto-conical camming surface against the radially inwardly projecting rib of the tubular housing member, resiliently biasing the radially inwardly projecting rib out of the way and receiving the annular end surface on the radially inwardly projecting rib. The cap is then attached over the open distal end of the tubular housing member and the piercing member is then inserted through the open proximate end of the tubular transfer member and connected to the cap as described above. Finally, the transfer set is sealingly attached to the first container, such as a vial, preferably by receiving the collar portion of the tubular housing member over the vial and radially deforming the free end into the neck portion of the vial or container.
The transfer set of this invention may then be used to transfer fluid between the first container to which it is attached and a second container through the tubular transfer member. In a typical application wherein the first container, such as a vial, contains a drug, vaccine, medicament or solution in dry or liquid form, and the material is ready for use, the cover or cap is removed by breaking the frangible connection between the central portion of the cap and the outer tubular portion, exposing the luer threads on the outer surface of the tubular transfer member adjacent the open distal end. The second container, such as a syringe without a needle canula having a female luer thread, is then threadibly attached to the male luer thread adjacent the distal end of the tubular transfer member. The tubular end portion of the syringe is thereby received within the tubular transfer member, driving the piercing member to pierce the pierceable closure, such as a conventional elastomeric stopper, providing fluid communication between the first container and the second container. In the preferred embodiment of the transfer set, wherein the piercing member is releasably attached to the cap as described above, the removal of the central portion of the cap releases the piercing member and the tubular portion of the syringe is then received against the piercing member distal end during threaded attachment as described above.